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Uncoated tablet:
-Disintegration test
-Uniformity of weight
Effervescent tablet:
-Disintegration test
-Uniformity of weight
Coated tablet:
-Disintegration test
-Uniformity of weight
INDIAN PHARMACOPOEIA
Uncoated tablet:
-Uniformity of container content
-Content of active ingredient
-Uniformity of weight
-Uniformity of content
-Disintegration test
Enteric coated tablet:
-Disintegration test
Dispersible tablet:
-Uniformity of dispersion
-Disintegration
Soluble tablet:
-Disintegration test
Effervescent tablet:
-Disintegration/ Dissolution / Dispersion
test
Procedure:
1. Weigh 20 tab altogether = W1
2. Put these tablets in the friabilator and adjust the
instrument at 100 rpm (i.e. = 25 rpm for 4 min)
3. Weigh the 20 tablets (only the intact ones) = W2
4. Friability (% loss) =
It must be less than or equal to1% but if more we
do not reject the tablets as this test is non-official.
Perform this test using 20 tablets that were used
first in the weight variation test
Liquids used in
disintegration
Water,
simulated gastric fluid
(PH = 1.2 HCl),
or Simulated intestinal
fluid (PH = 7.5,
KH2PO4 (phosphate
buffer) + pencreatin
enzyme +NaOH)
Limits:
For Uncoated tablets:
Medium
Temper Time
ature
limit
According to Simulated 37oC
Not
U.S.P.
gastric
exceed
fluid
30min
According to water
37oC
Not
B.P.
exceed
15min
Limit:
Upper limit = average weight + (average
weight * %error)
Lower limit = average weight - (average
weight * %error)
The individual weights are compared with
the upper and lower limits.
>>Not more than two of the tablets differ from
the average weight by more than the %
error listed, and no tablet differs by more
than double that percentage.
Average Weight of
Capsule
Percentage Deviation
10
300 mg or more
7.5